One of the most common gastrointestinal ailments to afflict modern man is gastroesophageal reflux disease (GERD). GERD includes such symptoms as heartburn, indigestion, sour stomach, dyspepsia and flatulent dyspepsia. The frequency of the occurrences of GERD is difficult to estimate, but it is reasonable to assume that a majority of individuals living in industrialized societies today suffer from it at one time or another. Dietary indiscretion appears on the surface to be the primary cause along with stress, but GERD actually has a multifactorial etiology. The extent of the problem is evidenced by the multitude of prescription and non-prescription remedies available to the sufferer and the billions of dollars spent annually on treatments for GERD.
Multiple factors contribute to the occurrence of GERD. These factors include: efficacy of the anti-reflux mechanism; volume of gastric fluid; potency of the refluxed material; efficiency of esophageal clearance; and tissue resistance of the esophageal mucosa. The extent and severity of reflux esophagitis depends not on gastroesophageal reflux alone, but also upon the volume of gastric juice available to reflux, the potency of the refluxed material, the interval that the refluxed material remains in the esophagus, and the ability of the esophageal tissue to withstand injury and to repair itself after injury.
Currently, treatments available over the counter, i.e. without a prescription from a physician, include antacid preparations, anti-gas preparations, combination antacid and anti-gas preparations, and bismuth containing compounds. More recently, histamine H-2 receptor antagonists, which are now available over the counter, and proton pump inhibitors, which are not currently available over the counter, have added substantially to the treatment armamentarium. However, none of these preparations addresses the multifactorial etiology of gastroesophageal reflux disease. Thus, a need has developed in the art for a composition for the treatment of GERD which addresses that multifactorial etiology.